FDA 510(k)

Echelon Endopath Staple Line Reinforcement

K-Nummer: K190937 · 2019-10-14

Entscheidungsdatum2019-10-14

ProduktcodeOXC

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Echelon Endopath Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2019-10-14 under 510(k) number K190937. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Echelon Endopath Staple Line Reinforcement?

Echelon Endopath Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2019-10-14. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K190937.

When did Echelon Endopath Staple Line Reinforcement receive FDA 510(k) clearance?

Echelon Endopath Staple Line Reinforcement received FDA 510(k) clearance on 2019-10-14, under 510(k) number K190937.

Who is the listed applicant for Echelon Endopath Staple Line Reinforcement?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Echelon Endopath Staple Line Reinforcement?

The FDA product code for Echelon Endopath Staple Line Reinforcement is OXC.

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Weitere Einträge mit Ethicon Endo-Surgery, LLC als Antragsteller

Alle 35 Geräte anzeigen →

Verwandte Geräte (Code: OXC)

K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC K221487NEOVEIL Staple Line ReinforcementGunze Limited K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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